To compare the primary endpoint (overall survival) between the two arms of the studySecondary endpoints are:Local progression-free survivalMetastases-free survivalCTCAE v3.0 toxicityChemotherapy dose intensityRadiotherapy dose intensity
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: overall survival
Secondary outcome
Secondary endpoints;
Local progression-free survival
Metastases-free survival
CTCAE v3.0 toxicity
Chemotherapy dose intensity
Radiotherapy dose intensity
Background summary
The standard treatemtn of patiënts with SCLC LD consists of 4 cycles of
chemotherapy
(generally platinum-derivates with etoposide). Concurrently with a part of the
chemotherapy radiotherapy is given to the lungtumor, mostly during the second
and the third cycle. The standard dose of radiotherapy is 45-50 Gray (Gy),
adminstered in 25-30 fractions. The optimal dose of radiotherapy, the optimal
frationation and the optimal timing of combination with chemotherapy is not
known. The best results reported in a phase III study are obtained with 4
cycles ofchemotherapye and radiotherapye 45 Gy/2 x per day 1.5 Gy, started on
day 1 van de chemotherapy. The 5-years survival was 26% in this study.
Improvement of these results can possibly be obtained by a higher dose of
radiotherapy. Based upon several phase II studies is chosen for av comparison
of 45 Gy/2xdd 1.5Gy/30 fractions with 66 Gy/1xdd 2Gy/33 fractions. The
chemotherapy is identical in both arms of the study
Study objective
To compare the primary endpoint (overall survival) between the two arms of the
study
Secondary endpoints are:
Local progression-free survival
Metastases-free survival
CTCAE v3.0 toxicity
Chemotherapy dose intensity
Radiotherapy dose intensity
Study design
Multicentre randomised phase III trial. Patients are randomised to one of the
two treatment arm with 1;1 randomisation: patients will be randomly allocated
to treatment, using a minimization procedure
Intervention
Control arm:
Four to six cycles of Cisplatin 25mg/m2 iv D1 Etoposide 100 mg/m2 D1-3 with
concurrent BD radiotherapy 45 Gy in 30 twice-daily fractions over 3 weeks, 5
days per week from day 22 of cycle 1
Experimental arm:
Four to six cycles of Cisplatin 25mg/m2 iv D1 Etoposide 100 mg/m2 D1-3 with
concurrent oD radiotherapy 66 Gy in 33 daily fractions over 6.5 weeks, 5 days
per week from day 22 of cycle 1
Study burden and risks
In the intervention-arm patients receive three more fractiions of
radiotherapy (33 i.po. 30). In the intervention-arm patients will be
irradiated during 6.5 weeks, in the standard-arm during three weeks.
The higher dose of radiotherapy can cause more acute and late toxicity.
Av. E. Mounier 83/11
1200 Brussel
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Av. E. Mounier 83/11
1200 Brussel
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Listed location countries
Age
Inclusion criteria
a)either sex, age *18 years
b) Performance status ECOG grade 0-1 (appendix 1).
c) Histologically or cytologically confirmed SCLC
d) No patients with mixed small-cell and non-small-cell histologic features
e) No history of previous malignancy in the last 5 years (except non melanomatous skin or in-situ
cervix carcinoma). Patients with previous malignancies (except breast cancer) and in remission for at least 5 years can be included.
f) Limited stage disease (Veterans Administration Lung Cancer Study Group) ie patients whose disease can be encompassed within a radical radiation portal.
g) No pleural or pericardial effusions proven to be malignant
h) RT target volume acceptable by the local radiotherapist
i) Pulmonary function
a. FEV1 >1 litre or 40% predicted value
b. KCO (DLCO/VA) >40%predicted
j) Maximum of one of the following adverse biochemical factors:
a. Serum alkaline phosphatase more than >1.5 times the upper limit of normal (ULN)
b. Serum sodium < Lower limit of Normal
c. Serum LDH > UNL
k) Normal serum creatinine and calculated creatinine clearance * 50 ml/min. If calculated creatinine
clearance is <50 ml/mn according to the Cockroft and Gault formula (appendix 5), an EDTA
clearance should be performed
l) Adequate haematological function
a. Neutrophils >1.5 x 109/l
b. Platelets >100 x 109/l
r) Patient has read the patient information sheet and has signed the consent form.
s) Patients available for follow-up
o) Considered fit to receive any of the trial regimens
Exclusion criteria
Other previous or concomitant illness or treatment which in the opinion of the clinician will
interfere with the trial treatments or comparisons
Prior surgical resection of the primary tumour, no prior radiotherapy for lung cancer
Considered fit to receive any of the trial regimens
Female patients must satisfy the investigator that they are not pregnant, or are not of childbearing
potential, or are using adequate contraception. Men must also use adequate
contraception, as etoposide is clastogenic.
Patients who are breastfeeding
Patients who are not available for adequate follow-up
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTN91927162 |
| CCMO | NL24565.018.08 |